DMCs: Maintaining Data Integrity in COVID-19 Climate

ABSTRACT

Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic. Since the outbreak of COVID-19, there has been disruption to clinical trial management including missed patient visits and assessments, laboratory tests not being performed and submitted, and lapses in study drug administration. There are electronic adjudication systems on the market that have real-time status reporting, and this enables the delivery of a streamlined, efficient, and transparent process for accurate event collection, with high quality results In a timely fashion. Craig McLendon is Senior Director, Adjudication & Data Monitoring Management, ICON Clinical Research Services The DMC has the ability to look across various subsets of the trial and different countries and regions to evaluate any differences in the treatment groups based on exposure and infection rates.